Duns Number:005146311
Device Description: 3-Port Manifold with Check Valves, Large Bore Stopcock Extension Set with Rotating Male Lu 3-Port Manifold with Check Valves, Large Bore Stopcock Extension Set with Rotating Male Luer Lock, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar
Catalog Number
2C8921
Brand Name
CLEARLINK
Version/Model Number
2C8921
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K932512,K932512
Product Code
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
dcb14567-4a5c-4db6-b428-7d2cbbd853ce
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50085412071713
Quantity per Package
48
Contains DI Package
00085412071718
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |